| CTRI Number |
CTRI/2024/12/077793 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How metoclopramide affects stomach contents in diabetes mellitus patients before surgery for elective procedures |
|
Scientific Title of Study
|
Effect of metoclopramide on gastric residual volume as measured by ultrasonography in diabetes mellitus patients undergoing elective surgeries: A randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hari Haran N |
| Designation |
First year junior resident |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anaesthesiology, AIIMS Bathinda, PUNJAB
Bathinda PUNJAB 151001 India |
| Phone |
09655601229 |
| Fax |
|
| Email |
hariharankrr489@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mayank Gupta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anaesthesiology, AIIMS Bathinda, PUNJAB
Bathinda PUNJAB 151001 India |
| Phone |
09655601229 |
| Fax |
|
| Email |
mayankgupta6682@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Hari Haran N |
| Designation |
First year junior resident |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anaesthesiology, AIIMS Bathinda, PUNJAB
Bathinda PUNJAB 151001 India |
| Phone |
09655601229 |
| Fax |
|
| Email |
hariharankrr489@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bathinda, Punjab,India,151001 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bathinda |
| Address |
Bathinda Punjab India 151001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hari Haran N |
All India Institute of Medical Sciences, Bathinda |
Department of Anaesthesiology Bathinda PUNJAB |
09655601229
hariharankrr489@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group A- diabetes mellitus patients will receive metoclopramide |
Diabetes mellitus patients posted for elective surgeries will be kept nil per oral for 8 hrs. Baseline HbA1c , fasting blood sugar , duration of diabetes mellitus , type of treatment received will be assessed. ASA standard monitors will be attached and widebore intravenous cannula secured. Gastric ultrasonography will be done before administering metoclopramide 10mg (2ml) and second time done 30 mins after giving metoclopramide. Based on gastric residual volume calculated through gastric ultrasound, risk of aspiration can be measured and informed to anaesthesiologist for anaesthesia and airway plan. Just before extubation third time gastric residual volume will be calculated through gastric ultrasound. After surgery , in post operative period nausea , vomiting, regurgitation and aspiration will be asked at 6 hrs, 12 hrs and 24 hrs. |
| Intervention |
group B- diabetes mellitus patients will receive placebo (normal saline) |
Diabetes mellitus patients posted for elective surgeries will be kept nil per oral for 8 hrs. Baseline HbA1c , fasting blood sugar , duration of diabetes mellitus , type of treatment received will be assessed. ASA standard monitors will be attached and widebore intravenous cannula secured. Gastric ultrasonography will be done before administering normal saline (2ml) and second time done 30 mins after giving normal saline. Based on gastric residual volume calculated through gastric ultrasound, risk of aspiration can be measured and informed to anaesthesiologist for anaesthesia and airway plan. Just before extubation third time again gastric residual volume will be calculated through gastric ultrasound. After surgery , in post operative period nausea , vomiting, regurgitation and aspiration will be asked at 6 hrs, 12 hrs and 24 hrs. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients between 18 and 65 years of age of either gender.
ASA-PS 2 or 3 patients with diabetes mellitus scheduled for elective surgeries under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to give consent.
patients with partial and total gastrectomies.
Patients undergoing gastro-intestinal surgeries.
patients who are allergic to study drug(metoclopramide)
patients who have increased intracranial pressure.
patients who are unable to lie in the right lateral decubitus position.
Factors responsible for gastroparesis other than diabetes mellitus (like pregnancy, hypothyroidism, multiple sclerosis)
Those who are on medications like opioids, anti-depressants, anti-cholinergics |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of metoclopramide on gastric residual volume as measured by ultrasonography in diabetes mellitus patients undergoing elective surgeries |
gastric residual volume measured before and 30 mins after administering drug or normal saline and just before extubation also. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To grade the aspiration risk by measuring gastric residual volume in diabetes mellitus patients.
To compare post operative nausea , vomiting, regurgitation and aspiration among two groups.
To assess whether any change in anaesthesia and airway plan based on gastric residual volume. |
post operative nausea, vomiting, regurgitation and aspiration assessed at 6 hrs,12 hrs and 24 hrs. |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/12/2024 |
| Date of Study Completion (India) |
16/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is about to compare the effect of metoclopramide on gastric residual volume as measured by ultrasonography in DM patients undergoing elective surgeries. All patients will be kept nil per oral for at least 8 hours before surgery. Baseline HbA1C, fasting blood sugar, duration of DM, treatment for DM, ASA-PS grade and duration of fasting in hours will be noted on arrival at the preoperative area. A wide bore intravenous line will be secured. ASA standard monitors will be attached, as well as baseline parameters will be recorded. After getting informed written consent, gastric ultrasonography will be done in right lateral decubitus position to assess the gastric residual volume -1 (GRV-1) by measuring the gastric antral cross-sectional area before administering metoclopramide or placebo. After that, metoclopramide 10 mg (2ml) intravenous will be given to one set of patients with DM (group A), and 2 ml NS (placebo) will be given to another set of patients with DM (group B). After 30 minutes, gastric ultrasonography will be done again in right lateral decubitus position to measure the gastric antral CSA. From the CSA of the gastric antrum, we will calculate GRV-2 by the following formula described by Perlas et al. [GRV: 27+ (14.6×RIGHT LATERAL CSA)-(1.28×AGE)} a) Low risk: patients who have a GRV of less than 1.5mL/kg. (b) High risk: patients who have a GRV of more than 1.5mL/kg. Before conveying GRV findings, the anaesthesiologists responsible for intraoperative management but blinded to the group allocation will be asked about the anaesthesia and airway plan. Then these GRV values will conveyed to the anaesthesiologists. Based on these GRV values, the anaesthesiologists will decide the anaesthesia plan and airway plan (GETA or SGA). Gastric ultrasonography will again be done at the end of surgery before extubation to measure GRV-3. In patients whom the surgery has been completed will assess the post operative nausea, vomiting, regurgitation and aspiration at 6 hrs, 12 hrs and at 24 hrs. Endpoint: Post operative nausea, vomiting, regurgitation and aspiration assessment for twenty-four hours after the completion of surgery. Primary objective: To evaluate the effect of metoclopramide on GRV as measured by ultrasonography in DM patients undergoing elective surgeries. Secondary objectives: (1) To grade the aspiration risk by measuring GRV in DM patients undergoing elective surgeries. (2) To compare post operative nausea, vomiting, regurgitation and aspiration among the two groups. (3) To assess whether there is any change in the anaesthesia and airway plan based upon gastric ultrasonography findings |